Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

PHOSLYRA (NDA-022581)

(CALCIUM ACETATE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

Download Data

Expand all

09/30/2020 (SUPPL-10)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Hypercalcemia

(Additions and/or revisions underlined)

Patients with kidney failure on dialysis may develop hypercalcemia when treated with calcium, including calcium acetate (PHOSLYRA). Avoid the concurrent use of calcium supplements, including calcium-based nonprescription antacids, with PHOSLYRA.

6 Adverse Reactions

6.1 Clinical Trials Experience

(Additions and/or revisions underlined)

The solid dose formulation of calcium acetate was studied in a 3-month, open-label, non- randomized study of 98 enrolled kidney failure on dialysis patients and in a two week double- blind, placebo-controlled, cross-over study with 69 enrolled kidney failure on dialysis patients. Adverse reactions (>2% on treatment) from these trials are presented in Table 1.

Table 1: Adverse Reactions in Patients with Kidney Failure on Dialysis Undergoing Hemodialysis

(Updated table title)

8 Use in Specific Populations

8.1 Pregnancy

Risk Summary

Administration of the recommended dose of PHOSLYRA is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Patients with kidney failure on dialysis may develop hypercalcemia with calcium acetate treatment [see Contraindications (4)] and [Warnings and Precautions (5.1)]. Maintenance of normal serum calcium levels is important for maternal and fetal wellbeing. There are adverse effects on maternal and fetal outcomes

associated with end-stage renal disease in pregnancy (see Clinical Considerations). Animal reproduction studies have not been conducted with PHOSLYRA.

Clinical Consideration

Disease-Associated Maternal and/or Embryo/Fetal Risk

Pregnancies that occur in women with kidney failure on dialysis are associated with a high rate of complications, including increased maternal mortality, hypertension, preeclampsia, anemia, intrauterine growth restriction, preterm delivery, and still birth.

Maternal and Fetal/Neonatal Adverse Reactions

Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism.

Monitor maternal serum calcium levels to maintain normal serum calcium.

Lactation

(PLLR conversion; additions and revisions underlined)

Risk Summary

Calcium and acetate are excreted in human milk. There are no data on the effects of calcium

acetate on the concentration of calcium or acetate in milk, the effect on the breastfed child, or the effects on milk production.